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HomeFunctioning of Directive 89/105/EEC relating to the transparency of measures regulating the prices and reimbursement of medicinal products (‘Transparency Directive’)
Final report
Publication metadata
Directive 89/105/EEC was adopted in December 1988. It relates to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (also referred to as the “Transparency Directive”). Its key objectives are to obtain an overview of national pricing arrangements, to provide public access to such information and to ensure that all concerned can verify that the national measures do not constitute quantitative restrictions on imports or exports. The Commission requested the present study to gain insight into the functioning of Directive 89/105/EEC, the benefits and challenges experienced by Member States, pharmaceutical producers and other stakeholders, and to set out some potential actions which could support the functioning of the Directive in its current form. The study also assesses how market conditions for medicinal products have changed since entry into force of the Directive and how this has impacted its functioning. As such, the study is not meant as a formal check of compliance nor as a formal evaluation of the Directive nor is it a step towards revising it.
- Published:
- Corporate author(s): Directorate-General for Health and Food Safety (European Commission) , European Health and Digital Executive Agency (European Commission) , Health Connect Partners , Netherlands Institute for Health Services Research , Netherlands National Institute for Public Health and the Environment , Royal College of Surgeons in Ireland University of Medicine and Health Sciences , Utrecht Institute for Pharmaceutical Sciences
- Themes: Pharmaceutical and cosmetics industry , Approximation of legislation
- Subject: directive (EU) , disclosure of information , EU Member State , health costs , health insurance , marketing , medicinal product , pharmaceutical legislation , pricing of medicines , report
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| ISSN | ISBN 978-92-95224-63-6 | DOI 10.2925/9257403 | Catalogue number HW-01-24-003-EN-N |
- Released on EU publications website:
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